Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)

A Randomized, Open Label Trial of Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02287259

Enrollment

Registered

2014-11-10

Start date

2014-11-30

Completion date

2019-03-31

Last updated

2019-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Brief summary

Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.

Interventions

DRUGolanzapine

DRUGlithium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point) * 18years to 65years * subjects who sign the informed consent document

Exclusion criteria

* don't have Diabetes and abnormal metabolism of sugar * not noticed as bipolar disorder * have an organic brain disease * pregnant or breastfeeding women * don't have heart disease * have actively suicidal thought(Suicidal ideation score of MADRS is 6) * who are judged by the investigator to should be excluded from the study

Design outcomes

Primary

Measure	Time frame
Change in Montgomery- Åsberg Depression Rating(MADRS)	Baseline and 8 weeks

Secondary

Measure	Time frame
Change in Young Mania Rating Scale(YMARS)	Baseline and 8 weeks
Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)	Baseline and 8 weeks
State Trait Anxiety Inventory Form JYZ(STAI)	Baseline and 8 weeks
Clinical Global Impression for Bipolar Disorder(CGI-BP)	Baseline and 8 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026